Ardo Bellis Manuel utilisateur

Taper
Manuel utilisateur
ardo bellis
electric breastpump
Instructions for use | Gebrauchsanweisung | Mode d'emploi |
Istruzioni per l’uso | Gebruiksaanwijzing | Instrucciones de uso
Instructions for Use
en Ardo Bellis – Electric breastpump 1 – 16
de Ardo Bellis – Elektrische Milchpumpe 17 – 31
fr Ardo Bellis – Tire-lait électrique 32 – 47
it Ardo Bellis – Tiralatte elettrico 48 – 62
nl Ardo Bellis – Elektrische borstkolf 63 – 77
es Ardo Bellis – Sacaleches eléctrico 78 – 92
Thank you for choosing the Ardo Bellis breastpump.
Vielen Dank, dass Sie sich für die Ardo Bellis Milchpumpe entschieden haben.
Nous vous remercions d’avoir opté pour le tire-lait Ardo Bellis.
Grazie per aver scelto il tiralatte Ardo Bellis.
Hartelijk dank dat u gekozen hebt voor de Ardo Bellis borstkolf.
Muchas gracias por haber elegido el sacaleches Ardo Bellis.
FG
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LK
A
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Ardo Bellis
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Breast Shell Sizes
Ø 36 mmØ 31 mmØ 26 mm
Ø 26 mm
Ø 28 mm
Ø 22 mm
= Ø size
en
The breast shell size is correct if:
the nipple moves freely in the funnel and can follow the rhythmic movements of the breastpump.
no part, or very little, of the areola is in the funnel.
the milk fl ows and the breast feels uniformly soft after expression.
de
Die Brustglocke passt wenn:
die Brustwarze sich frei im Trichter bewegt und den rhythmischen Bewegungen der Pumpe folgen kann.
sich kein oder nur wenig Gewebe des Brustwarzenhofes im Trichter befi ndet.
die Muttermilch fl iesst und sich die Brust nach dem Abpumpen überall weich anfühlt.
fr
La téterelle est adaptée :
lorsque le mamelon se déplace librement dans l’entonnoir et peut suivre les mouvements rythmiques du tire-lait.
lorsque le tissu de l’aréole ne pénètre pas ou quasiment pas lentonnoir.
si le lait maternel s’écoule et que le sein semble détendu partout après l’expression.
it
La misura della coppa va bene se:
il capezzolo si muove liberamente nell’imbuto e può seguire i movimenti ritmici della pompa.
solo se nessuna parte o poca parte dell'areola del capezzolo si trova nell’imbuto.
il latte defl uisce e dopo lestrazione il seno è morbido al tatto.
nl
De borstschelp past wanneer:
de tepel vrij in de trechter beweegt en de ritmische bewegingen van de borstkolf kan volgen.
zich geen of maar weinig weefsel van de tepelhof in de trechter bevindt.
de moedermelk stroomt en de borst na het afkolven overal zacht aanvoelt.
es
El embudo para pecho es adecuado si...
los pezones se mueven libremente en el embudo al extraer la leche y siguen los movimientos rítmicos del sacaleches.
si hay poco o ningún tejido de la areola del pezón en el embudo.
la leche materna fl uye y el pecho se siente suave por todas partes después de la extracción.
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b
ad
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ardo bellis Electric Breastpump
1. Product description
aArdo Bellis breastpump
bConnection port for pumpset
cPower adapter with USB cable
dConnection opening for USB power adapter
Ardo Bellis is a vacuum pump for collecting breast milk and is intended for use at home and in professional environment.
It expresses in two phases (stimulation and expression modes) that imitate the sucking behaviour of the baby.
With Ardo Bellis you can express milk from one breast or both breasts at the same time.
The German text is the reference for the contents.
Instructions for the accessories: Only use Ardo pumpsets. Breast shells are available in the sizes ø 22 / 26 / 28 / 31, and
36 mm (see accompanying instructions for use for “Pumpset and accessories”).
1.2 Control elements and symbols
The illustrations of the control elements and symbols are located on the fold-out page of the cover. The active elements or
symbols light up.
AOn/Off button (standby button) Switches the breastpump on and off
BMemory Plus button Press the Memory Plus button: Saves the expression history of a pumping session.
Memory Plus button lights up: Sequence is saved but is not displayed.
Memory Plus button flashes: Saved expression history is displayed.
CPower Pumping button Automatically starts the Power Pumping program (interval pumping over an hour).
The different segments light up green (during expressing) or white (during the
pauses) depending on the progress of the interval pumping.
DBluetooth® Shows the connection of the breastpump via Bluetooth
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EBattery display Shows the charge level of the rechargeable battery
FVacuum display Step indicator for vacuum (suction level)
GCycle display Step indicator for cycle (suction frequency)
HVacuum buttons Increase or decrease the vacuum (suction level)
ICycle buttons Increase or decrease the cycle (suction frequency)
JMode button Displays the current mode and enables manual switching between stimulation and
expression modes
KStimulation mode Upper semicircle lights up orange in stimulation mode
LExpression mode Lower semicircle lights up green in expression mode
MTimer Displays the expressing time
2. Important safety
instructions and warnings
Ardo Bellis is an electrically operated reliable medical device. It has been developed and is manufactured according to CE
guidelines and the relevant safety standards. For your safety and to prevent damage to the device and to avoid the risk of
electric shock, injury, or fire, please follow the safety instructions below.
READ THE INSTRUCTIONS FOR USE COMPLETELY BEFORE USING THIS
BREASTPUMP.
Not following these instructions for use may lead to damage to the device or personal injury.
KEEP THESE INSTRUCTIONS FOR USE.
For help with the initial setup or if something unexpected happens, please contact the point of sale, the hire center, or the
customer service team at the manufacturer Ardo medical AG.
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Note to the user
Any complaints, problems, or safety concerns should be reported to the manufacturer or the distributor.
In the European Union (according to Regulation (EU) 2017/745 on medical devices) any serious incidents occurring in rela-
tion with the product must be reported to the manufacturer and the competent authorities in the Member State in which the
user resides.
Risk due to contamination / infection
To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
Only use original Ardo pumpsets. If parts from other manufacturers are used, there is a risk of microbial contamination of
parts as well as the breast milk because the parts are not compatible.
Risk of health problems and serious injuries
This device must not be used during pregnancy because expressing breast milk can start contractions.
Do not use this device while driving a car (even as a passenger).
Do not use this breastpump if you are overtired and may fall asleep during use, because this may lead to irritation of the
nipples.
Make sure that this device is not used unsupervised by children or by people with reduced mental capabilities.
Ardo Bellis may only be used for the purposes described in Chapter 3. For all uses apart from the intended use, all warranty
and liability claims against the manufacturer are excluded.
Risk of an electric shock
The Ardo Bellis breastpump with the power adapter is only suitable for use indoors. Do not use outdoors.
Only use this breastpump with the supplied Ardo original USB cable and power adapter.
Ensure that the power adapter can always be easily accessed.
Ardo Bellis is not waterproof.
- The device must therefore not be immersed in water or other liquids nor used or stored in locations where it could
fall into water.
- Do not use in the bath or when showering.
- Do not clean in the dishwasher, under running water, or by immersing in water.
- The pump unit must not be used if it has fallen into water or is wet. If this happens, contact your service partner or
the manufacturer!
This breastpump must not be opened or modified in any way without the permission of the manufacturer. It does not
contain any parts that are maintained by the user.
Handle this device with care and avoid all shocks, blows, or vibrations (e.g., do not allow it to drop onto the floor). If this
device is nevertheless exposed to one of the mechanical effects described above, carefully inspect the device for damage
before the next use. If the device is damaged, contact the point of sale, the hire center or the customer service team at
Ardo medical AG.
Risk of fire or toxic vapors
Keep the pump unit, USB cable with power adapter, and accessories away from sources of heat.
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Risk of damage to the device or an unwanted change in the vacuum
Do not insert or suck up any objects or liquids into the tube connector port of the device.
Risk of injury due to the vacuum generated by the device or strangulation
Make sure that the device is not used unsupervised by children or by people with reduced mental capabilities.
Risk of incorrect mode of operation and reduction of the performance characteristics
Using this device near other devices or stacked with other devices should be avoided.
Portable and mobile RF communication equipment (radio devices including their accessories such as antennas and
external antennas) should not be used at a distance less than 30 cm (or 12 inches) from the parts and cords of the
device labeled by the manufacturer.
The use of accessories, power adapters, and cords other than those defined or provided by the manufacturer of this
device may result in increased electromagnetic noise emissions or a reduced electromagnetic immunity for the device and
lead to a faulty mode of operation.
Cybersecurity: The device is protected from piracy and unauthorized use. I If you have any indication of a violation of
cybersecurity protection please contact the manufacturer.
3. Intended use
The Ardo Bellis electric breastpump is used to express and collect breast milk from lactating or, to be more precise, from
breastfeeding women by generating a defined vacuum at the breast. It can be used for single or double pumping. The
breastpump is intended for use indoors. The Ardo Bellis breastpump is intended for multiple users.
4. Operation and expressing
You can find more information about operating and using Ardo Bellis at www.ardomedical.com.
If you need additional help, please contact the point of sale, the hire center, or the customer service team at Ardo medical AG
or speak to a lactation consultant or midwife.
4.1 Terms used
2-phase breastpump Ardo Bellis expresses in two phases: the stimulation and the expression modes, which imitate
the sucking behavior of the baby. This means a rapid cycle (suction frequency) with low
vacuum (suction level) to stimulate the let-down reflex and a high vacuum with a slow cycle
for efficient suction.
Stimulation mode A rapid cycle (suction frequency) and low vacuum (suction level) start the breast milk flowing
or trigger the let-down reflex.
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Expression mode Slower cycle (suction frequency) and high comfortable vacuum (suction level) for efficient
expressing of breast milk once the let-down reflex has been triggered.
Cycles Suction frequency / suction speed
Vacuum Suction level
Single pumping Expressing from one breast
Double pumping Expressing from both breasts
Let-down reflex A reflex that starts the breast milk flowing.
Memory Plus Saves the personal expression history including settings and time in stimulation and
expression mode. When the breastpump is next switched on, the saved expression history
starts.
Power Pumping Interval pumping over one hour to increase the breast milk volume
“Vacuum Seal” technology Closed pump system with hygiene barriers in the breast shell itself.
4.2 Start-up
WARNING: Risk due to contamination / infection
To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
You can operate Ardo Bellis with the enclosed USB cable or the integrated rechargeable battery.
Mains operation
Pull the flap down, insert the USB cable into the USB port on the breastpump, and connect the power adapter to the mains
power supply.
Battery operation
It is not necessary to fully charge the rechargeable battery before the first use. You can connect Ardo Bellis with the USB
power adapter and charge the rechargeable battery during the first five hours of use at the same time (see Chapter 5).
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4.3 Preparing the Ardo Bellis breastpump
4.3.1 Connecting the pumpset
Single pumping
Attach the tube connec-
tor to the Ardo Bellis.
The second opening of
the tube connector stays
closed.
Double pumping
Open the second opening
of the tube connector and
connect the tube of the
second pumpset. Connect
the tube connector to the
Ardo Bellis.
The use of the pumpset is described in the enclosed instructions for use “Pumpset and accessories”.
4.3.2 Visual inspection before each use
Every time you use the breastpump, check that …
… the USB cable and power adapter are undamaged.
… the pumpset is clean, correctly assembled, and intact.
… the pumpset is correctly connected.
4.4 Operation and procedure for expressing
Warning: Risk due to contamination / infection
To prevent contamination of your breast milk, thoroughly wash your hands with soap and water before each use.
4.4.1 Basic functions—step-by-step procedure
1Find a comfortable position for expressing, hold the pumpset on the breast shell, and center the nipple.
2Press the On/Off button to start expressing.
3The breastpump is in stimulation mode.
This can be seen by the upper segment of the mode button that lights up orange.
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4Adjust the vacuum (suction level) and the cycle (suction frequency) to what is comfortable for you.
The vacuum and the cycle can be increased using the button or decreased using the button. By pressing the
particular button, the intensity of the vacuum or cycle is changed by one step or bar.
5After two minutes, the stimulation mode switches automatically to the expression mode .
a) If the breast milk starts to flow before this, press the mode button to manually switch to the expression
mode.
b) If the let-down reflex has not been triggered after the preset two minutes, press the mode button to extend
the stimulation by another two minutes.
6The breastpump is in expression mode.
This can be seen by the lower segment of the mode button that lights up green.
7Adjust the vacuum (suction level) and the cycle (suction frequency) to what is comfortable for you.
The vacuum and the cycle can be increased using the button or decreased using the button. By pressing the
particular button, the intensity of the vacuum or cycle is changed by one step or bar.
Expressing is most successful if you select the vacuum and cycle settings that are comfortable for you.
8The timer starts automatically when the Ardo Bellis is switched on and continuously displays the
expressing time.
9Massage the breast while expressing. This increases the volume of milk expressed.
10 By holding down the On/Off button , you can switch off the breastpump.
4.4.2 Silent Start
If the Ardo Bellis is switched on but not connected to a pumpset, it runs very quietly without pumping.
When the pumpset is inserted, you can start to express (see Chapter 4.4).
4.5 Memory function—Individual expressing at the touch of a button
You have found your ideal settings when your breast milk flows freely and you can express most successfully. Activating the
memory button saves your expression history. When you next switch the breastpump on, you can automatically express
using the saved expression history in the stimulation mode and then in expression mode. The Ardo Bellis breastpump stops
automatically after the saved time.
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You can nevertheless change the values for the vacuum and cycle manually at any time and define a new time for the length
of the expression history. This takes you out of save mode. When you have finished expressing, you can save any changes to
the expression history. If you do not save the new values, the previous settings are kept.
Whenever the Memory Plus button is lit up, your expression history is saved and when the breastpump is switched on, it
automatically starts to express using your personal data.
Using the Memory Plus function—step-by-step procedure
1Expressing
Express using your favorite settings.
2Saving an expression history
At the end of your expressing session, press the Memory Plus button to save your individual expression history.
As confirmation, you will hear a tone, the button lights up, and the breastpump automatically switches off.
3Accessing your expression history
Switch the breastpump on. You express straightaway using the saved data. The Memory Plus button flashes
slowly throughout.
Deleting data
You can delete the saved data at any time if you do not want to express with the memory function. By holding down the
Memory Plus button once, the saved data is deleted and the button no longer lights up.
4.6 Power Pumping—Increasing the milk volume
Automatic Power Pumping is a pre-defined one-hour interval pumping program—
expressing three times with two pauses—that aims to increase the volume of milk
you produce. During the pauses you can remove the pumpset and move around
freely.
The operation corresponds to the basic functions (see Chapter 4.4.1). The progress of
the expressing is indicated by the green and white segments that light up.
Power Pumping imitates the natural sucking behavior of babies. There are times—
usually in the evenings—when newborns or older babies want to be breastfed at
10-minute intervals to stimulate milk production (cluster feeding). More information
can be found in Chapter 7.4.
= Expression = Pause
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Using the Power Pumping function—step-by-step procedure
Expressing
Switch the breastpump on and press the Power Pumping button.
First expressing phase
The first segment of the button starts to light up green and the breastpump starts in stimulation mode. You
can adjust the vacuum and the cycle to what is comfortable for you. After two minutes, Ardo Bellis switches
to the expression mode. Again, you can select the vacuum and cycle that work for you. The color of the
mode button tells you which mode the breastpump is in.
First pause
After 20 minutes a tone sounds and the first 10 minute pause starts. The second segment of the button
lights up white. At the end of the pause, a reminder signal sounds.
You then have 5 minutes to press the Power Pumping button and continue expressing (during this time, the
segments flash and a regular beep sounds). Otherwise, the breastpump switches off.
Second expressing phase
Ardo Bellis expresses for 10 minutes. The settings for vacuum and cycle from the first expressing phase are
used automatically. However, you can adjust these values at any time to suit your needs.
Second pause
After 10 minutes a tone sounds and the second pause starts (see first pause for the sequence).
Third expressing phase
The settings for vacuum and cycle from the second expressing phase are used. However, you can adjust
these values at any time to suit your needs. After 10 minutes the Power Pumping stops and Ardo Bellis
switches off automatically.
The time indicator counts down the specified time in each phase.
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5 Battery operation
The breastpump has a built-in rechargeable battery. The battery cannot be replaced. The rechargeable battery is
automatically charged when the supplied power adapter is connected to the mains power. The charging time is
about 2 hours.
If the device is operated while the battery is charging, the charging time is extended. Only use the power adapter and
the USB cable that are supplied with the breastpump.
It is not necessary to fully charge the rechargeable battery before the first use. The device can be operated with mains
power and the rechargeable battery will be charged at the same time during the first 5 hours of use.
You can express about 8 times with a fully charged battery.
Air travel: The Ardo Bellis has a lithium ion rechargeable battery. Please check if there are national restrictions on carrying
lithium ion batteries when flying.
Charging the rechargeable battery
Insert the USB power adapter into the breastpump and connect it to the mains power.
When charging, the indicator moves from left to right until the battery is fully charged and the three bars light up white.
If the last bar of the battery symbol lights up red, the breastpump needs to be recharged soon.
6 Cleaning / maintenance
Cleaning at home
Disconnect the breastpump from the mains power before cleaning. Wipe the device as needed with a damp cloth and normal
dishwashing liquid. Please follow the safety instructions in Chapter 2.
Cleaning the pumpset
The cleaning instructions for the pumpset are described in the enclosed instructions for use for the
“Pumpset and accessories”.
Reprocessing at the hire center
More detailed information is included in the service instructions.
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7 Useful tips for expressing
7.1 Triggeringthelet-downreex
The let-down reflex may occur later when expressing than when breastfeeding. The following measures may help the breast
milk to flow in addition to the stimulation mode:
Relax and think about your baby.
Look at a video or photo of your baby.
Massage the breast before expressing.
Extend the stimulation mode (see Chapter 4.4.1).
Place a warm compress on the breast before expressing.
7.2 Comfortable settings for vacuum and cycle
What determines the level of the vacuum is your personal well-being and not the maximum vacuum that can be set.
Therefore, express using your comfortable vacuum setting. This will help you to express more breast milk, your breast milk
will flow better, and your nipples will remain intact.
7.3 Combination of massage and expressing
When you massage the breast while using the breastpump, this can increase your milk production and improve the milk flow.
7.4 Increasing the milk volume—Power Pumping
Use the unique automatic Power Pumping function of the Ardo Bellis over one hour (see Chapter 4.6) in addition to your
usual breastfeeding or expressing routine.
Express from both breasts at the same time if possible. Double pumping increases the milk volume.
Use the special bra for double pumping or take an old bra and cut out a hole for the breast shells.
Use the 10 minute pauses to relax, drink a little, eat something, have a shower, read a book, listen to some music, do
small chores around the house, and so on.
Use the Power Pumping 1–2 times a day.
It may be that in the first few days you can only express a few drops. Don’t worry about this and persevere with the
Power Pumping. By regularly stimulating your breasts, the milk volume will increase. It may take 3–4 days or even longer
until the volume of breast milk increases.
The expressed breast milk only has to be placed in the refrigerator at the end of the Power Pumping.
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7.5 Pain when expressing
Expressing must not be painful. If it hurts, the following possible reasons must be eliminated:
The vacuum is set too high. Adjust the settings so that they are comfortable for you (see Chapter 7.2).
The nipples are not centered. Ensure that your nipples are in the middle of the breast shell.
The funnel of the breast shell does not fit. It is too small or too big. The breast shell size is right if:
- your nipples move freely in the funnel when expressing and track the rhythmical movements of the breastpump
(about 3 mm space between the funnel and the nipple).
- none or only a little bit of the areola is located in the funnel.
- the breast milk flows and the breast feels soft all over after the expressing.
The breastpump with the pumpset is switched on before positioning the breast shell. As a result, the nipple is difficult
to center.
Order the correct size breast shell from Ardo, your specialist retailer, or your qualified consultant. Ardo has the following
breast shell sizes in stock: ø 22 / 26 / 28 / 31, and 36 mm (see fold-out page).
8 Troubleshooting
The breastpump barely sucks or does not suck at all
Ensure that the pumpset has been correctly assembled and is not damaged (see instructions for use for the
“Pumpset and accessories“).
Check that the pumpset is connected firmly to the breastpump.
Check whether the USB cable and the power adapter are correctly attached and connected to the mains power.
If these steps do not resolve the problem, please contact the point of sale, the hire center, or the customer service team at
the manufacturer Ardo medical AG.
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9 Spare parts
Ardo Bellis breastpump (body) Art. no. 63.00.521
USB cable with power adapter EU Art. no. 63.00.541
USB cable with power adapter UK Art. no. 63.00.542
USB cable with power adapter US Art. no. 63.00.543
USB cable with power adapter AU Art. no. 63.00.544
USB cable with power adapter CN Art. no. 63.00.545
USB cable with power adapter KR Art. no. 63.00.546
Pumpset See instructions for use for the “Pumpset and accessories”
10 Warranty
The warranty period for the Ardo Bellis breastpump is 1 year after the purchase date; the receipt with the date is considered
to be the certificate of warranty. The warranty period for the lithium ion rechargeable battery for the Ardo Bellis is 6 months
after the purchase date; the receipt with the date is considered to be the certificate of warranty.
10.1 General terms and conditions
Ardo medical AG guarantees that the products manufactured by it are free from material and manufacturing defects.
With proper use, any faulty material will be replaced free of charge during the warranty period. To preserve the right to
make any warranty claims and to ensure the flawless function of the device, the instructions for use must be followed
and only accessories from Ardo medical AG are to be used. The warranty coverage will be void if modifications are made
in or to the device.
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11 Technical information / symbols
11.1 Technical data
Pump unit
Vacuum pump type moderate vacuum, low flow rate
Vacuum range at 0–2000 MAMSL 30–330 mbar
Weight 620 g
Battery capacity 2600 mAh
Dimensions 210 × 150 × 90 mm
Protection class Class II
Applied part Class BF
BLE radio frequency band 2.4 GHz ISM
IP protection class IP 22 (protected against solid objects up to 12 mm and protection
against dripping water when the housing is tilted at up to 15°)
Life time of device incl. power adapter 800 hours
Operating conditions +5°C to +40°C
10% to 93% RH
700–1060 hPa
Storage and transport conditions -10°C to +60°C
10% to 93% RH
700–1060 hPa
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Power adapter
Input voltage 100–240 V, 50/60 Hz, max. 0.5 A
Output voltage 5 V / 2.0 A (*2.1 A)
Max. cable length 1.5 m
IP protection class IPX0 (no protection against solid objects or water)
Approved models EU: MKC-0502000VEUU (#99.05.025)
EU: XY-0030A (#99.05.025)*
UK: MKC-0502000VUKU (#99.05.026)
UK: XY-0030AUK (#99.05.026)*
US: MKC-0502000VU (#99.05.027)
US: XY-0030A (#99.05.027)*
AU: MKC-0502000VAUU (#99.05.028)
AU: XY-0030AAU (#99.05.028)*
CN: MKC-0502000XXX (#99.05.029)
CN: XY-0030ACN (#99.05.029)*
KR: MKC-0502000XXX (#99.05.030)
KR: XY-0030AKC (#99.05.030)*
11.2 Symbols
Safety instructions / warnings Alternating current
Read and follow the instructions for use Direct current
012
3
Compliance with valid European regulations for
medical devices Temperature
Manufacturer Air pressure
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Device with applied part BF Relative humidity
The device is subject to the provisions of the WEEE
Directive 2002/96/EC Store protected from sunlight
Protection class Keep the packaging away from moisture
Vacuum
Setting for the vacuum (suction level) Cycles Setting for the cycles (suction frequency)
Medical Device
Device complies with the requirements (Part 15)
of the Federal Communications Commission
(FCC)
E358823
MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
ANSI/AAMI ES60601-1 (2005, C1:09, A2:10), CAN/CSA C22.2 No.60601.1 (2008, R:2011)
12 Disposal
The device can be returned to the manufacturer or be dismantled and recycled in an environmentally responsible manner by
a recycling company specializing in electric devices. There are no special or increased risk factors. Waste must be disposed of
in compliance with local regulations.
13 Electromagnetic compatibility
The Ardo Bellis breastpump meets all the relevant requirements for the applicable standards relating to interference
emissions and immunity for operation in medical and domestic environments.
More information about the electromagnetic tests is provided in the chapter “Emission and Immunity Tests” (page 93).
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Ardo Bellis Manuel utilisateur

Taper
Manuel utilisateur